DiarrheaNCT01072110
Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
An observational study of Diarrhea, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Colonoscopy and Confocal Laser Endomicroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of a tertiary referral hospital.
Who may be able to join
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
Who cannot join
- Inability to provide written informed consent
- Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
- Impaired renal function (Creatinine > 1.2 mg/dl)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
- Known allergy to fluorescein, acriflavin or cresyl violet
- Residing in institutions (e.g. prison)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confocal Laser Endomicroscopy in Patients With Diarrhea
The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
Read the detailed description
Background:
Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
Scope:
In patients with diarrhea.
Methods:
Patients were randomized in two groups. Group 1: Patients underwent standard video colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure CLE will be performed additionally.
Procedure:
The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
- Conditions
- Diarrhea
- Being tested
- Colonoscopy, Confocal Laser Endomicroscopy
- Keywords
- Patients with diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Patients will undergo colonoscopy for evaluation of their symptoms.
Confocal Laser EndomicroscopyProcedure or surgery
Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients with diarrhea undergoing endoscopy | Standard video colonoscope. Receives: Procedure: Colonoscopy | |
| Group 2: Patients with diarrhea undergoing endoscopy. | Confocal laser endomicroscopy (CLE). Receives: Procedure: Confocal Laser Endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
Measured: February 2012
Secondary outcomes (1)
To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea.
Measured: February 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus F. Neurath, M.D., Ph.D., Principal investigator, Department of Medicine I, University of Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072110
- Sponsor's protocol ID
- HN-0001
- Status last verified
- Dec 2020
- First submitted
- 17 Feb 2010
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy in Patients With Diarrhea
- ClinicalTrials.gov ID
- NCT01072110
- Acronym / sponsor ID
- HN-0001
- Conditions
- Diarrhea
- Keywords
- Patients with diarrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
Detailed description
Background:
Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
Scope:
In patients with diarrhea.
Methods:
Patients were randomized in two groups. Group 1: Patients underwent standard video colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure CLE will be performed additionally.
Procedure:
The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients with diarrhea undergoing endoscopy | – | Procedure: ColonoscopyStandard video colonoscope. |
| Group 2: Patients with diarrhea undergoing endoscopy. | – | Procedure: Confocal Laser EndomicroscopyConfocal laser endomicroscopy (CLE). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of a tertiary referral hospital.
Key inclusion criteria (4 listed)
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
Key exclusion criteria (7 listed)
- Inability to provide written informed consent
- Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
- Impaired renal function (Creatinine > 1.2 mg/dl)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyPatients will undergo colonoscopy for evaluation of their symptoms. | Procedure or surgery | Group 1: Patients with diarrhea undergoing endoscopy |
| Confocal Laser EndomicroscopyPatients will undergo CLE during their endoscopy. Findings will be compared to group 1. | Procedure or surgery | Group 2: Patients with diarrhea undergoing endoscopy. |
Primary outcome
To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
Time frame: February 2012
1 secondary outcome
To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea.
Time frame: February 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus F. Neurath, M.D., Ph.D. principal investigator
Department of Medicine I, University of Erlangen-Nuremberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy. (time frame: February 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.